Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality. Regarding Rheumatoid Arthritis

NCT01919645 | Completed

• 1 other identifier: AHK2013
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Physical exercise programs are effective and safe for the improvement of the sleep efficiency in patients with Rheumatoid Arthritis.

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis; Sleep Disorders; Polysomnography; Sleep Stages; Physical Exercise

Outcome Measures

Primary Outcomes (1)

• Improvement of sleep through a polysomnogram exam.

  Evaluation of N3 stage of the sleep through a polysomnogram before and after 16 weeks of supervised exercises.

  at baseline and at end-week 16

Study Arms (2)

Combined Training Group

EXPERIMENTAL

Combined Training - (strength + aerobics). A combined training (CT)is performed, having aerobics exercises (AE)using a stationary bicycle and strength training in workout devices. The strength training (ST) will be performed by isotonic exercises recruiting the main muscle groups. They exercises are: Chest Press, Leg Press, Vertical Traction, Leg Extension and Abdominal Crunch.

Other: Combined Training ( Strength + Aerobics)

Control Group

PLACEBO COMPARATOR

The control group patients did not perform any intervention through physical exercises. They were oriented on Sleep Hygiene and were followed during the study. They were asked to come to the following visits (at weeks 8 and 16) and to 2 additional visits to get and then return the actigraph. During this period, they were followed through phone calls once a month and were asked for sleep hygiene and were reminded of their assessment dates.

Other: Combined Training ( Strength + Aerobics)

Interventions

Combined Training ( Strength + Aerobics) OTHER

Strength training performed using workout devices and aerobic training performed using stationary bicycle.

Combined Training Group; Control Group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ages 35-65 years diagnosed with Rheumatoid Arthritis according with the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR)Criteria; Pittsburgh Sleep Quality Index ≥ 5; electrocardiogram test (ECG) at rest and at regular effort.

You may not qualify if:

• Patients with joint restrictions due to disease.
• Other rheumatoid-associated diseases (Fibromyalgia) with the exception of Osteoarthritis of low degree.
• Those who are uncontrollably hypertense, diabetic, with thyroidopathy and cardiorespiratory diseases which stop them from practicing exercises.
• Class II obesity (IMC ≥ 35 Kg/m2).
• Cognitive deficits.
• Depression.
• Patients not following the study rules such as exercise hours and / or time for the proposed program.
• Current physical exercise practitioner.
• Those undergoing medication treatment which would interfere sleep.
• Night shift workers who disrespect regular working schedule.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Centro de Estudos em Psicobiologia e Exercício (CEPE) da Associação Fundo de Incentivo a Pesquisa (AFIP)

São Paulo, São Paulo, 04026-001, Brazil

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Sleep Wake Disorders; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Andrea H Kayo, PHD student

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: August 3, 2013
• First Posted: August 9, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 2, 2016

Record last verified: 2016-08

Locations

BR (1)